Cord Blood Banking Accreditation Standards

Cord blood banking requires strict standards to ensure the safe collection, processing, and storage of stem cells. Accreditation from organizations like AABB and FACT ensures that banks follow rigorous protocols, providing high-quality, reliable services for families and patients.

Key Takeaways:

• AABB Accreditation: Focuses on quality management and technical standards, with evaluations every two years.
• FACT Accreditation: Emphasizes clinical outcomes and requires banks to store at least 500 units before inspection.
• Benefits: Accreditation ensures safety, quality, and compliance with global standards, giving families peace of mind.

Quick Comparison:

Accreditation is crucial for ensuring that cord blood banks meet high standards, benefiting both families and medical professionals.

AABB Accreditation Standards

AABB Requirements

AABB sets clear standards for accrediting cord blood banks, combining technical expertise with quality management systems. This ensures consistent and reliable operations in cord blood banking.

To qualify for AABB accreditation, cord blood banks must satisfy the following conditions:

• Operational Timeline: Facilities need to operate for at least six months before starting the accreditation process. This period helps establish operational consistency.
• Assessment Phases: The accreditation process includes two main steps:
  • A comprehensive self-assessment
  • An on-site evaluation conducted by AABB experts
• Documentation and Procedures: Banks must implement and document quality management systems in line with AABB standards.

AABB allows facilities to demonstrate their commitment to quality and safety while raising trust amongst donors, patients, and clients. In addition, having a third-party endorsement differentiates you from competitors and gives you a broader opportunity to increase your overall footprint.
– Marc Lewis, Vice President of Operations, Gulf Coast Regional Blood Center

These requirements not only ensure operational excellence but also offer practical advantages for banks and families.

Impact on Banks and Families

Accreditation by AABB guarantees safety and quality while promoting risk management and ongoing improvements. With its program active in over 50 countries, AABB establishes global benchmarks for cord blood banking.

Here’s how AABB accreditation benefits cord blood banks:

• Provides external validation of operational excellence.
• Identifies risks, quality violations, and areas for improvement.
• Ensures continuous quality oversight through regular standard updates and facility evaluations ¹.

AABB accreditation is often linked to FDA BLA approvals, as seen in institutions like NY Blood Center and Duke University Medical Center:

These examples highlight how AABB accreditation supports facilities in achieving top-tier quality and safety, directly benefiting families who bank their newborn’s cord blood.

FACT Accreditation Standards

FACT Requirements and Process

The Foundation for the Accreditation of Cellular Therapy (FACT) has established strict guidelines for cord blood banking to ensure safe and high-quality practices in collection, processing, and storage.

Here are some key requirements for achieving FACT accreditation:

• Minimum Banking Volume: Facilities must store at least 500 cord blood units before undergoing inspection.
• Active Operations: Banks need to demonstrate ongoing collection and storage activities.
• Regulatory Compliance: Registration with appropriate governmental authorities is mandatory.
• Qualified Leadership: Banks must appoint skilled individuals to key roles, including Bank Director, Medical Director, Collection Director, Processing Facility Director, and Quality Unit Manager.

The accreditation process involves several steps:

1. Initial Setup: Submit a bank profile and eligibility application.
2. Documentation: Provide a compliance application along with supporting materials.
3. Inspection: Participate in an on-site evaluation conducted by FACT.
4. Review: Address any issues identified during the inspection and make necessary corrections.
5. Certification: Receive a three-year accreditation upon meeting all requirements.

Impact on Quality and Care

By adhering to FACT's detailed procedures, cord blood banks can enhance service quality and improve patient outcomes. These standards are grounded in research on the clinical results of cord blood transplants.

Some benefits of FACT accreditation include:

• Enhanced Quality Systems: Accredited banks implement robust monitoring systems and use standardized coding systems like ISBT 128 or Eurocode.
• Clear Documentation: For international operations, all required documents must be translated into English before inspection.

To maintain accreditation, banks are required to:

• Submit renewal applications 11 months before the current accreditation expires.
• Stay aligned with updated standards.
• Participate in periodic audits and inspections.

These measures help ensure that accredited facilities consistently provide reliable, high-quality services while keeping pace with advancements in the field.

AABB vs FACT Standards

Main Differences

AABB and FACT both uphold high standards for cord blood banking, but their methods differ. FACT focuses on clinical outcomes supported by research, while AABB combines international quality management practices with specific technical standards.

AABB conducts on-site evaluations every two years following a self-assessment process. FACT, on the other hand, assigns dedicated coordinators to handle document reviews and inspections. FACT's guidelines are comprehensive, covering every stage of cord blood banking for both unrelated and related/allogeneic or autologous units. Meanwhile, AABB emphasizes an adaptable framework with requirements like infectious disease testing.

Here's a quick comparison of their key differences:

Standards Comparison Table

The major objective of the NetCord FACT Standards is to promote quality medical and laboratory practices throughout all phases of cord blood banking to achieve consistently high-quality cord blood units available to patients for lifesaving treatments. - FACT ²

Both systems are rigorous but differ in focus. FACT prioritizes research-backed criteria to ensure therapeutic reliability, while AABB offers operational flexibility paired with strict quality measures. Understanding these distinctions can help you choose the right accreditation for your needs.

Accreditation Process Guide

Getting Accredited

Accrediting a cord blood bank requires detailed planning and thorough documentation. Although both AABB and FACT have multi-step processes, their specific requirements and steps differ.

For AABB accreditation, the process typically spans 1–2 years:

• Initial Documentation Phase
  Submit necessary paperwork, such as the Membership Application for new facilities or Personnel Contact Information for new activities. This step also includes processing the dues invoice.
• Self-Assessment Phase
  Use the APEX system to complete a self-assessment, ensuring compliance by documenting detailed policies, processes, and procedures.
• On-Site Assessment
  After approval of the self-assessment, an on-site evaluation is conducted. Any identified issues must be resolved to finalize accreditation.

For FACT accreditation, the focus is on cross-referencing documents and working closely with inspectors:

• Application Process
  Set up a profile in the Accreditation Portal and submit the Eligibility Application along with the registration fee.
• Documentation Review
  Provide detailed documentation in the Compliance Application, signed by the Cord Blood Bank Director and Facility Directors. Include a crosswalk that links each standard to its supporting documents.
• Inspection Phase
  Collaborate with FACT inspectors to complete the on-site evaluation.

Keeping Accreditation

Once accredited, maintaining high standards is essential. AABB-accredited facilities undergo assessments every two years, while FACT-accredited banks need to submit their Compliance Application 11 months before their accreditation expires.

Key practices for maintaining accreditation include:

• Regularly updating policies and keeping detailed records
• Ensuring key personnel are available during assessments
• Responding promptly to documentation requests
• Continuously monitoring internal compliance

Americord Registry Case Study

This case study highlights how Americord integrates industry standards into its operations to deliver reliable and advanced services.

Americord's Standards and Services

Americord Registry meets industry standards through its accreditation by AABB. The company operates its in-house lab 24/7, using pharmaceutical-grade clean rooms to process perinatal stem cells and tissues. This ensures compliance with strict requirements for personnel, facilities, equipment, and quality assurance.

We are thrilled to receive AABB accreditation for our in-house lab. This achievement underscores our commitment to providing our customers with the highest level of confidence and peace of mind when it comes to preserving their newborn's stem cells. The AABB accreditation reinforces our position as an industry leader and reflects our commitment to the future of regenerative medicine. - Martin Smithmyer, CEO of Americord

Parent Services and Options

Using its accredited processes, Americord provides families with secure and advanced preservation options. Its CryoMaxx™ Processing technology ensures high-quality preservation and collects up to twice as many stem cells as the industry average.

Americord also offers flexible pricing, with payment plans starting at $145 per month for 24 months at 0% interest. Pricing is subject to change, for the most up-to-date prices visit https://production.americordblood.com/pricing. Annual Fees (in some cases) may apply. Notably, it is the first private biobank to preserve exosomes - tiny vesicles essential for cell communication, currently being explored in clinical trials for potential therapeutic uses.

Summary

Importance of Standards

Accreditation standards are the backbone of quality assurance in cord blood banking. Organizations like AABB and FACT set guidelines that integrate global quality management principles with technical specifications, ensuring every stage of the banking process meets rigorous criteria.

AABB standards focus on thorough quality and technical benchmarks, verified through on-site evaluations every two years. On the other hand, FACT standards require banks to store a minimum of 500 units and implement standardized coding systems. Both sets of standards are developed by expert committees, relying on up-to-date scientific research, manufacturing practices, and regulatory guidelines.

Choosing a Bank

While accreditation is a critical factor, it’s not the only one. Parents should also evaluate a bank's overall performance and reliability to ensure long-term trust. These high standards serve as a roadmap for selecting a bank that prioritizes both quality and dependability.

The FDA plays a regulatory role by requiring mandatory registration, but certain banks take it a step further by securing FDA licensing. This involves meeting stricter Biological License Application standards, offering families an added layer of confidence when exploring cord blood banking options.

References:

¹ AABB. (n.d.). Accreditation Programs: Cord Blood Banks. Retrieved from https://www.aabb.org/accreditation/cord-blood-banks

² FACT. (n.d.). NetCord-FACT Cord Blood Bank Standards. Retrieved from https://www.factweb.org/cord-blood-bank-standards